LED Therapy for the Treatment of Concussive Brain Injury

• ClinicalTrials.gov Identifier: NCT02383472
• Recruitment Status: Completed
• First Posted: March 9, 2015
• Results First Posted: June 29, 2018
• Last Update Posted: July 26, 2018
• Sponsor: Boston Children's Hospital
• Collaborators: United States Department of Defense; National Football League
• Information provided by (Responsible Party): William Meehan III, Boston Children's Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Brain Concussion
• Interventions: Device: MedX Health Console model 1100; Device: MedX Health Console model 1100-placebo
• Enrollment: 53

Participant Flow

Recruitment Details	Recruitment began in the September of 2012 from the Concussion Clinic within the Department of Sports Medicine and lasted through the spring on 2016.
Pre-assignment Details

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Period Title: Overall Study
Started	23	30
Completed	22	29
Not Completed	1	1
Reason Not Completed
Withdrawal by Subject	1	1

Baseline Characteristics

Arm/Group Title		MedX Health Console Model 1100	MedX Health Console Model 1100-placebo	Total
Arm/Group Description		The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.	Total of all reporting groups
Overall Number of Baseline Participants		22	29	51
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	22 participants	29 participants	51 participants
		21.55 (13.12)	21.21 (13.25)	21.35 (13.19)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	29 participants	51 participants
	Female	13 59.1%	19 65.5%	32 62.7%
	Male	9 40.9%	10 34.5%	19 37.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	29 participants	51 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	2 6.9%	2 3.9%
	White	22 100.0%	27 93.1%	49 96.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Participants taking stimulant medications; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	29 participants	51 participants
		10 45.5%	14 48.3%	24 47.1%
Migraine Headache; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	29 participants	51 participants
		2 9.1%	7 24.1%	9 17.6%
Psychiatric hx; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	22 participants	29 participants	51 participants
Undefined		14 63.6%	22 75.9%	36 70.6%
Anxiety		1 4.5%	0 0.0%	1 2.0%
Depression		0 0.0%	3 10.3%	3 5.9%
PTSD		1 4.5%	0 0.0%	1 2.0%
Neurodevelopmental Diagnosis; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	22 participants	29 participants	51 participants
ADHD		5 22.7%	2 6.9%	7 13.7%
Learning Disability		1 4.5%	2 6.9%	3 5.9%
Prior Concussions; Mean (Full Range); Unit of measure: Concussions
	Number Analyzed	22 participants	29 participants	51 participants
		3.5; (1 to 10)	2; (1 to 6)	2.5; (1 to 10)
Injury characteristics; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	22 participants	29 participants	51 participants
Sport-related concussion		14 63.6%	22 75.9%	36 70.6%
Loss of Consciousness		3 13.6%	3 10.3%	6 11.8%
Amnesia		8 36.4%	10 34.5%	18 35.3%

Outcome Measures

1. Primary Outcome

Title	Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.
Description	The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.
Time Frame	From baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description:	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine except it does not have LED lights on the marker, therefore it cannot emit light. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
Overall Number of Participants Analyzed	22	29
Mean (Standard Deviation); Unit of Measure: Units on a scale
Verbal Memory	-0.9 (17.11)	-5.78 (12.08)
Visual Memory	3.52 (14.82)	-7.26 (12.07)
Visual Motor Speed	-2.04 (6.36)	-5.15 (5.04)
Reaction Time	-0.001 (0.16)	0.030 (0.18)
Symptom Score	10.14 (10.13)	11.44 (19.07)

2. Secondary Outcome

Title	Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.
Description	This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.
Time Frame	From baseline to 3 weeks and from baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description:	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
Overall Number of Participants Analyzed	22	29
Mean (Standard Deviation); Unit of Measure: Seconds
D-KEFs Color Naming - 3 Weeks	3.27 (4.03)	4.76 (8.88)
D-KEFs Color Naming - 6 Weeks	3.76 (5.12)	4.07 (9.00)
D-KEFs Word Reading - 3 Weeks	0.95 (2.98)	4.07 (10.05)
D-KEFs Word Reading - 6 Weeks	1.71 (3.73)	3.44 (13.98)
D-KEFs Inhibition - 3 Weeks	7.64 (5.49)	4.48 (17.00)
D-KEFs Inhibition - 6 Weeks	32.62 (9.13)	31.59 (14.73)
D-KEFs Number Sequencing - 3 weeks	-24.45 (15.04)	-21.17 (17.55)
D-KEFs Letter Sequencing- 3 weeks	-28.41 (14.06)	-19.51 (20.15)
D-KEFs Number-Letter Sequencing- 3 weeks	8.00 (12.66)	21.93 (32.19)
D-KEFs Number Sequencing - 6 weeks	11.33 (7.3)	6.89 (10.78)
D-KEFs Letter Sequencing- 6 weeks	6.86 (4.29)	10.59 (9.49)
D-KEFs Number-Letter Sequencing- 6 weeks	12.95 (13.28)	19.81 (30.34)

3. Secondary Outcome

Title	Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.
Description	This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs Verbal Fluency Test, made up of letter fluency and category fluency, is measured by number of responses, a larger number represents a better outcome. Participants were given 60 seconds to complete each fluency test.
Time Frame	From baseline to 3 weeks and from baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description:	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
Overall Number of Participants Analyzed	22	29
Mean (Standard Deviation); Unit of Measure: Correct responses
D-KEFs Verbal Fluency- letters 3 weeks	-3.45 (6.52)	-6.10 (8.26)
D-KEFs Verbal Fluency- letters 6 weeks	-6.71 (7.89)	-9.89 (11.34)
D-KEFs Verbal Fluency- category 3 weeks	-1.14 (4.17)	-0.03 (4.12)
D-KEFs Verbal Fluency- category 6 weeks	-1.62 (4.09)	-2.00 (4.62)

4. Secondary Outcome

Title	Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.
Description	This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.
Time Frame	From baseline to 3 weeks and from baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description:	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
Overall Number of Participants Analyzed	22	29
Mean (Standard Deviation); Unit of Measure: units on a scale
PCSS Total Score - 3 Weeks	9.41 (12.62)	7.03 (16.96)
PCSS Total score - 6 Weeks	7.86 (14.5)	14.63 (23.41)

5. Secondary Outcome

Title	Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6
Description	This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like "in a fog", "don't feel right", difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome.
Time Frame	From baseline to 3 weeks and from baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MedX Health Console Model 1100	MedX Health Console Model 1100-placebo
Arm/Group Description:	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. Treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar	Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. Placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
Overall Number of Participants Analyzed	22	29
Mean (Standard Deviation); Unit of Measure: units on a scale
Cognitive Sx Score - 3 Weeks	3.95 (6.56)	1.31 (6.96)
Cognitive Sx Score - 6 Weeks	4.00 (6.59)	5.00 (8.95)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MedX Health Console Model 1100		MedX Health Console Model 1100-placebo
Arm/Group Description	The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100: All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal ar		Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp. MedX Health Console model 1100-placebo: The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the r
All-Cause Mortality
	MedX Health Console Model 1100		MedX Health Console Model 1100-placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	MedX Health Console Model 1100		MedX Health Console Model 1100-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0.00%)		0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	MedX Health Console Model 1100		MedX Health Console Model 1100-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.35%)		0/30 (0.00%)
Skin and subcutaneous tissue disorders
Discomfort * [1]	1/23 (4.35%)	1	0/30 (0.00%)	0
* Indicates events were collected by non-systematic assessment; [1] Patient complained cluster heads were "uncomfortable and hot"

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. William Meehan
• Organization: Boston Children's Hospital
• Phone: 781-216-1328
• EMail: William.Meehan@childrens.harvard.edu

Publications:

Naeser MA, Zafonte R, Krengel MH, Martin PI, Frazier J, Hamblin MR, Knight JA, Meehan WP 3rd, Baker EH. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014 Jun 1;31(11):1008-17. doi: 10.1089/neu.2013.3244. Epub 2014 May 8.

Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.

Cantu RC. Chronic traumatic encephalopathy in the National Football League. Neurosurgery. 2007 Aug;61(2):223-5. doi: 10.1227/01.NEU.0000255514.73967.90. No abstract available.

Collins MW, Lovell MR, Iverson GL, Cantu RC, Maroon JC, Field M. Cumulative effects of concussion in high school athletes. Neurosurgery. 2002 Nov;51(5):1175-9; discussion 1180-1. doi: 10.1097/00006123-200211000-00011.

Gronwall D, Wrightson P. Cumulative effect of concussion. Lancet. 1975 Nov 22;2(7943):995-7. doi: 10.1016/s0140-6736(75)90288-3.

Guskiewicz KM, Marshall SW, Bailes J, McCrea M, Cantu RC, Randolph C, Jordan BD. Association between recurrent concussion and late-life cognitive impairment in retired professional football players. Neurosurgery. 2005 Oct;57(4):719-26; discussion 719-26. doi: 10.1093/neurosurgery/57.4.719.

Guskiewicz KM, Mihalik JP, Shankar V, Marshall SW, Crowell DH, Oliaro SM, Ciocca MF, Hooker DN. Measurement of head impacts in collegiate football players: relationship between head impact biomechanics and acute clinical outcome after concussion. Neurosurgery. 2007 Dec;61(6):1244-52; discussion 1252-3. doi: 10.1227/01.neu.0000306103.68635.1a.

Guskiewicz KM, McCrea M, Marshall SW, Cantu RC, Randolph C, Barr W, Onate JA, Kelly JP. Cumulative effects associated with recurrent concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2549-55. doi: 10.1001/jama.290.19.2549.

Jordan BD, Relkin NR, Ravdin LD, Jacobs AR, Bennett A, Gandy S. Apolipoprotein E epsilon4 associated with chronic traumatic brain injury in boxing. JAMA. 1997 Jul 9;278(2):136-40.

McKee AC, Cantu RC, Nowinski CJ, Hedley-Whyte ET, Gavett BE, Budson AE, Santini VE, Lee HS, Kubilus CA, Stern RA. Chronic traumatic encephalopathy in athletes: progressive tauopathy after repetitive head injury. J Neuropathol Exp Neurol. 2009 Jul;68(7):709-35. doi: 10.1097/NEN.0b013e3181a9d503.

Omalu BI, DeKosky ST, Hamilton RL, Minster RL, Kamboh MI, Shakir AM, Wecht CH. Chronic traumatic encephalopathy in a national football league player: part II. Neurosurgery. 2006 Nov;59(5):1086-92; discussion 1092-3. doi: 10.1227/01.NEU.0000245601.69451.27.

Beauchamp K, Mutlak H, Smith WR, Shohami E, Stahel PF. Pharmacology of traumatic brain injury: where is the "golden bullet"? Mol Med. 2008 Nov-Dec;14(11-12):731-40. doi: 10.2119/2008-00050.Beauchamp. Epub 2008 Aug 18.

Mittenberg W, Burton DB. A survey of treatments for post-concussion syndrome. Brain Inj. 1994 Jul;8(5):429-37. doi: 10.3109/02699059409150994.

Zafonte R, Friedewald WT, Lee SM, Levin B, Diaz-Arrastia R, Ansel B, Eisenberg H, Timmons SD, Temkin N, Novack T, Ricker J, Merchant R, Jallo J. The citicoline brain injury treatment (COBRIT) trial: design and methods. J Neurotrauma. 2009 Dec;26(12):2207-16. doi: 10.1089/neu.2009.1015.

Meehan WP 3rd. Medical therapies for concussion. Clin Sports Med. 2011 Jan;30(1):115-24, ix. doi: 10.1016/j.csm.2010.08.003.

Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics. 2009 Jan;123(1):114-23. doi: 10.1542/peds.2008-0309.

Ommaya AK, Gennarelli TA. Cerebral concussion and traumatic unconsciousness. Correlation of experimental and clinical observations of blunt head injuries. Brain. 1974 Dec;97(4):633-54. doi: 10.1093/brain/97.1.633. No abstract available.

Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235.

Yamakami I, McIntosh TK. Effects of traumatic brain injury on regional cerebral blood flow in rats as measured with radiolabeled microspheres. J Cereb Blood Flow Metab. 1989 Feb;9(1):117-24. doi: 10.1038/jcbfm.1989.16.

Yoshino A, Hovda DA, Kawamata T, Katayama Y, Becker DP. Dynamic changes in local cerebral glucose utilization following cerebral conclusion in rats: evidence of a hyper- and subsequent hypometabolic state. Brain Res. 1991 Oct 4;561(1):106-19. doi: 10.1016/0006-8993(91)90755-k.

Yuan XQ, Prough DS, Smith TL, Dewitt DS. The effects of traumatic brain injury on regional cerebral blood flow in rats. J Neurotrauma. 1988;5(4):289-301. doi: 10.1089/neu.1988.5.289.

Mochizuki-Oda N, Kataoka Y, Cui Y, Yamada H, Heya M, Awazu K. Effects of near-infra-red laser irradiation on adenosine triphosphate and adenosine diphosphate contents of rat brain tissue. Neurosci Lett. 2002 May 3;323(3):207-10. doi: 10.1016/s0304-3940(02)00159-3.

Yu W, Naim JO, McGowan M, Ippolito K, Lanzafame RJ. Photomodulation of oxidative metabolism and electron chain enzymes in rat liver mitochondria. Photochem Photobiol. 1997 Dec;66(6):866-71. doi: 10.1111/j.1751-1097.1997.tb03239.x.

Oron A, Oron U, Streeter J, de Taboada L, Alexandrovich A, Trembovler V, Shohami E. low-level laser therapy applied transcranially to mice following traumatic brain injury significantly reduces long-term neurological deficits. J Neurotrauma. 2007 Apr;24(4):651-6. doi: 10.1089/neu.2006.0198.

McCrory P, Meeuwisse W, Johnston K, Dvorak J, Aubry M, Molloy M, Cantu R. Consensus statement on concussion in sport - The 3rd international conference on concussion in sport held in Zurich, November 2008. PM R. 2009 May;1(5):406-20. doi: 10.1016/j.pmrj.2009.03.010. No abstract available.

Collins M, Lovell MR, Iverson GL, Ide T, Maroon J. Examining concussion rates and return to play in high school football players wearing newer helmet technology: a three-year prospective cohort study. Neurosurgery. 2006 Feb;58(2):275-86; discussion 275-86. doi: 10.1227/01.NEU.0000200441.92742.46.

Field M, Collins MW, Lovell MR, Maroon J. Does age play a role in recovery from sports-related concussion? A comparison of high school and collegiate athletes. J Pediatr. 2003 May;142(5):546-53. doi: 10.1067/mpd.2003.190.

Lovell MR, Collins MW, Iverson GL, Field M, Maroon JC, Cantu R, Podell K, Powell JW, Belza M, Fu FH. Recovery from mild concussion in high school athletes. J Neurosurg. 2003 Feb;98(2):296-301. doi: 10.3171/jns.2003.98.2.0296.

Lovell MR, Collins MW, Iverson GL, Johnston KM, Bradley JP. Grade 1 or "ding" concussions in high school athletes. Am J Sports Med. 2004 Jan-Feb;32(1):47-54. doi: 10.1177/0363546503260723.

Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available.

Stuss DT, Ely P, Hugenholtz H, Richard MT, LaRochelle S, Poirier CA, Bell I. Subtle neuropsychological deficits in patients with good recovery after closed head injury. Neurosurgery. 1985 Jul;17(1):41-7. doi: 10.1227/00006123-198507000-00007.

• Responsible Party: William Meehan III, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02383472
• Other Study ID Numbers: IRB-P00002527
• First Submitted: March 4, 2015
• First Posted: March 9, 2015
• Results First Submitted: March 21, 2018
• Results First Posted: June 29, 2018
• Last Update Posted: July 26, 2018